38726 Federal Register / Vol. 86, No. 138 / Thursday, July 22, 2021 / Notices 

providing clinical services (currently 7, 

previously 8) related to Healthy People 

2020 and; 

(7) removal of the outdated project 

specific Health Improvement Special 

Project measure (1 measure removed). 

In total, the proposed changes reflect 

the addition of 43 measures and the 

removal of 5 measures for an increase in 

measures by a total of 38 measures. Of 

these measures, 17 are required and 26 

are optional. All additional measures 

proposed are project specific (only 

applicable to anticipated total ranging 

from 15–16 out of 61 awardees). All 

measures will not be applicable to all 61 

respondents. Project specific measures 

will remain applicable only to Outreach 

Awardees focusing on the respective 

project specific topic. 

Likely Respondents: The respondents 

would be award recipients of the Rural 

Health Care Services Outreach Program. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; develop, 

acquire, install, and utilize technology 

and systems for the purpose of 

collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; complete and review the 

collection of information; and transmit 

or otherwise disclose the information. 

The total annual burden hours 

estimated for this ICR are summarized 

in the table below. 

Total Estimated Annualized Burden 

Hours: 

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Rural Health Care Services Outreach PIMS ....................... 61 1 61 3.5 213.5 

61 ........................ 61 ........................ 213.5 

HRSA specifically requests comments 

on the: (1) Necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions; (2) accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–15607 Filed 7–21–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: The Advisory 

Committee on Heritable Disorders in 

Newborns and Children’s Public Health 

System Assessment Surveys, OMB No. 

0906–0014, Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than September 20, 

2021. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Lisa Wright-Solomon, the HRSA 

Information Collection Clearance Officer 

at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

The Advisory Committee on Heritable 

Disorders in Newborns and Children’s 

Public Health System Assessment 

Surveys, OMB No. 0906–0014— 

Revision. 

Abstract: The purpose of the Public 

Health System Assessment Surveys is to 

inform the Advisory Committee on 

Heritable Disorders in Newborns and 

Children (Committee) on states’ ability 

to add newborn screening for particular 

conditions, including the feasibility, 

readiness, and overall capacity to screen 

for a new condition. 

The Committee was established under 

the Public Health Service Act, 42 U.S.C. 

217a: Advisory councils or committees, 

and Title XI § 1111 (42 U.S.C. 300b-10). 

The purpose of the Committee is to 

provide the Secretary with 

recommendations, advice, and technical 

information regarding the most 

appropriate application of technologies, 

policies, guidelines, and standards for: 

(a) Effectively reducing morbidity and 

mortality in newborns and children 

having, or at risk for, heritable 

disorders; and (b) enhancing the ability 

of state and local health agencies to 

provide for newborn and child 

screening, counseling, and health care 

services for newborns and children 

having, or at risk for, heritable 

disorders. Specifically, the Committee 

makes systematic evidence-based 

recommendations on newborn screening 

for conditions that have the potential to 

change the health outcomes for 

newborns. 

The Committee tasks an external 

workgroup to conduct systematic 

evidence-based reviews for conditions 

being considered for addition to the 

Recommended Uniform Screening 

Panel, and their corresponding newborn 

screening test(s), confirmatory test(s), 

and treatment(s). Reviews also include 

an analysis of the benefits and harms of 

newborn screening for a selected 

condition at a population level and an 

assessment of state public health 

newborn screening programs’ ability to 

implement the screening of a new 

condition. 

Need and Proposed Use of the 

Information: The Committee’s Evidence 

Review Group administers the surveys 

to collect data from state newborn 

screening programs in the United States. 


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Federal Register / Vol. 86, No. 138 / Thursday, July 22, 2021 / Notices 38727 

The surveys have been developed to 

capture the following: (1) Readiness of 

state public health newborn screening 

programs to expand newborn screening 

to include the target condition, (2) 

specific requirements of screening for a 

condition that could hinder or facilitate 

implementation in each state, and (3) 

estimated timeframes needed for each 

state to complete major milestones 

toward full implementation of newborn 

screening for the condition. 

The following is a summary of 

proposed changes to the Committee’s 

Public Health System Assessment 

Surveys: 

Proposed changes to the ‘‘INITIAL 

Survey of the Secretary’s Advisory 

Committee on Heritable Disorders in 

Newborns and Children’s Public Health 

System Assessment:’’ 

• Survey title: 

Æ Current title: ‘‘INITIAL Survey of 

the Secretary’s Advisory Committee on 

Heritable Disorders in Newborns and 

Children’s Public Health System 

Assessment’’ 

Æ Proposed change: (strike 

‘‘Secretary’s’’) ‘‘INITIAL Survey of the 

Advisory Committee on Heritable 

Disorders in Newborns and Children’s 

Public Health System Assessment’’ 

Æ Rationale: Per the charter signed on 

November 10, 2020, the Advisory 

Committee on Heritable Disorders in 

Newborns and Children is the correct 

name for the Committee. 

• Introductory paragraph: 

Æ Current introductory paragraph: 

‘‘The purpose of this survey is to inform 

the Secretary of Health and Human 

Services Advisory Committee on 

Heritable Disorders in Newborns and 

Children (Committee) about states’ 

ability to add newborn screening (NBS) 

for [condition x] using information 

gathered from most of the state and 

territorial NBS programs in the U.S. 

. . .’’ 

Æ Proposed change: (strike ‘‘Secretary 

of Health and Human Services’’) ‘‘The 

purpose of this survey is to inform the 

Advisory Committee on Heritable 

Disorders in Newborns and Children 

(Committee) about states’ ability to add 

newborn screening (NBS) for [condition 

x] using information gathered from most 

of the state and territorial NBS programs 

in the U.S. . . .’’ 

Æ Rationale: Per the charter signed 

November 10, 2020, the Advisory 

Committee on Heritable Disorders in 

Newborns and Children is the correct 

name of the Committee. 

• Instructions for question 3 

(grammatical edit): 

Æ Current instructions: ‘‘. . . The 

following question asks you to consider, 

in general, how much the following 

factors would be an issue in considering 

adding [condition x] to your NBS 

panel.’’ 

Æ Proposed change: (strike ‘‘in’’ and 

replace with ‘‘when’’) ‘‘. . . The 

following question asks you to consider, 

in general, how much the following 

factors would be an issue when 

considering adding [condition x] to your 

NBS panel.’’ 

Æ Rationale: Change made to correct 

a grammatical error. 

Proposed changes to the ‘‘FOLLOW– 

UP Survey of the Secretary’s Advisory 

Committee on Heritable Disorders in 

Newborns and Children’s Public Health 

System Assessment’’ 

• Survey title: 

Æ Current title: ‘‘INITIAL Survey of 

the Secretary’s Advisory Committee on 

Heritable Disorders in Newborns and 

Children’s Public Health System 

Assessment’’ 

Æ Proposed change: (strike 

‘‘Secretary’s’’) ‘‘INITIAL Survey of the 

Advisory Committee on Heritable 

Disorders in Newborns and Children’s 

Pub. 

Æ Rationale: Per the charter signed 

November 10, 2020, the Advisory 

Committee on Heritable Disorders in 

Newborns and Children is the correct 

name of the Committee. 

• Question 9 (grammatical edits): 

Æ Current question: ‘‘Have you 

developed a follow up protocol and/or 

educational materials for [condition x]? 

If so please describe the steps for shortterm follow and how the plan was 

developed.’’ 

Æ Proposed change: (insert hyphen in 

‘‘follow-up’’ and insert ‘‘-up’’ in the 

phrase ‘‘short-term follow’’) ‘‘Have you 

developed a follow-up protocol and/or 

educational materials for [condition x]? 

If so, please describe the steps for shortterm follow-up and how the plan was 

developed. 

Æ Rationale: Change made to correct 

grammatical errors. 

The data gathered informs the 

Committee on the following: (1) 

Feasibility of implementing populationbased screening for the target condition, 

(2) readiness of state newborn screening 

programs to adopt screening for the 

condition, (3) gaps or limitations related 

to the feasibility or readiness of states to 

screen for a condition, and (4) areas of 

technical assistance and resources 

needed to facilitate screening for 

conditions with low feasibility or 

readiness. 

Likely Respondents: The respondents 

to the survey will be state and territorial 

newborn screening programs. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number 

of respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

INITIAL Survey of the Advisory Committee on Heritable 

Disorders in Newborns and Children’s Public Health 

System Assessment ......................................................... 1 59 3 2 118 10.0 1,180 

FOLLOW–UP Survey of the Advisory Committee on Heritable Disorders in Newborns and Children’s Public 

Health System Assessment ............................................. 2 30 3 2 60 2.0 120 

Total .............................................................................. 89 ........................ 178 ........................ 1,300 

* It is anticipated that the proposed revisions will not impact the estimated annualized burden hours. 

1The respondents to the survey will be state and territorial newborn screening programs. 


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38728 Federal Register / Vol. 86, No. 138 / Thursday, July 22, 2021 / Notices 

2 Up to 30 states and/or territories will be asked to complete a follow-up survey. 

3 Up to two conditions may be reviewed per year. 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–15598 Filed 7–21–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the Advisory Committee on 

Heritable Disorders in Newborns and 

Children 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In accordance with the Public 

Health Service Act and the Federal 

Advisory Committee Act, this notice 

announces that the Advisory Committee 

on Heritable Disorders in Newborns and 

Children (ACHDNC or Committee) has 

scheduled a public meeting to be held 

on Thursday, August 12, 2021, and 

Friday, August 13, 2021. Information 

about the ACHDNC and the agenda for 

this meeting can be found on the 

ACHDNC website at https://

www.hrsa.gov/advisory-committees/ 

heritable-disorders/index.html. 

DATES: Thursday, August 12, 2021, from 

10:00 a.m. to 2:15 p.m. Eastern Time 

(ET) and Friday, August 13, 2021, from 

10:00 a.m. to 2:00 p.m. ET. 

ADDRESSES: This meeting will be held 

via webinar. While this meeting is open 

to the public, advance registration is 

required. 

Please register online at https://

www.achdncmeetings.org/registration/ 

by the deadline of 12:00 p.m. ET on 

August 11, 2021. Instructions on how to 

access the meeting via webcast will be 

provided upon registration. 

FOR FURTHER INFORMATION CONTACT: 

Alaina Harris, Maternal and Child 

Health Bureau, HRSA, 5600 Fishers 

Lane, Rockville, Maryland 20857; 301– 

443–0721; or ACHDNC@hrsa.gov. 

SUPPLEMENTARY INFORMATION: ACHDNC 

provides advice and recommendations 

to the Secretary of HHS (Secretary) on 

the development of newborn screening 

activities, technologies, policies, 

guidelines, and programs for effectively 

reducing morbidity and mortality in 

newborns and children having, or at risk 

for, heritable disorders. The ACHDNC 

reviews and reports regularly on 

newborn and childhood screening 

practices, recommends improvements in 

the national newborn and childhood 

screening programs, and fulfills 

requirements stated in the authorizing 

legislation. In addition, ACHDNC’s 

recommendations regarding inclusion of 

additional conditions for screening, 

following adoption by the Secretary, are 

evidence-informed preventive health 

services provided for in the 

comprehensive guidelines supported by 

HRSA through the Recommended 

Uniform Screening Panel pursuant to 

section 2713 of the Public Health 

Service Act (42 U.S.C. 300gg–13). Under 

this provision, non-grandfathered group 

health plans and health insurance 

issuers offering group or individual 

health insurance are required to provide 

insurance coverage without cost-sharing 

(a co-payment, co-insurance, or 

deductible) for preventive services for 

plan years (i.e., policy years) beginning 

on or after the date that is one year from 

the Secretary’s adoption of the 

condition for screening. 

During the August 12–13, 2021, 

meeting, ACHDNC will hear from 

experts in the fields of public health, 

medicine, heritable disorders, rare 

disorders, and newborn screening. 

Agenda items include the following: 

(1) Overview of the Committee’s 

review of its evidence-review processes 

and proposed updates, 

(2) A presentation on phase one of the 

mucopolysaccharidosis type II evidence 

review, 

(3) Guanidinoacetate 

methyltransferase (GAMT) deficiency 

nomination summary, 

(4) Possible Committee vote on 

whether to move GAMT deficiency 

forward to a full evidence review, 

(5) Committee discussion on emerging 

issues for newborn screening, 

(6) A panel presentation on national 

registries followed by Committee 

discussion, 

(7) A panel presentation on emerging 

issues facing the newborn screening 

workforce followed by Committee 

discussion, and 

(8) Public comments on any newborn 

screening related topic. 

The public is also encouraged to 

provide public comment on the 

proposed updates to the Committee’s 

evidence review processes. For 

reference, a summary of questions for 

public consideration is on the ACHDNC 

website. We request that public 

participants providing oral comments 

on the review of the Committee’s 

evidence review process also submit a 

written version of their remarks. 

The agenda for this meeting does not 

include any vote or decision to 

recommend a condition for inclusion in 

the Recommended Uniform Screening 

Panel. As noted in the agenda items, the 

Committee may hold a vote on whether 

or not to recommend a nominated 

condition (GAMT deficiency) to full 

evidence review, which may lead to 

such a recommendation at a future time. 

Agenda items are subject to change as 

priorities dictate. Information about the 

ACHDNC, including a roster of members 

and past meeting summaries, is 

available on the ACHDNC website listed 

above. 

As previously noted, members of the 

public will have the opportunity to 

provide comments. Public participants 

providing general oral comments may 

submit written statements in advance of 

the scheduled meeting. Oral comments 

will be honored in the order they are 

requested and may be limited as time 

allows. Requests to provide a written 

statement or make oral comments to the 

ACHDNC must be submitted via the 

registration website by 10:00 a.m. ET on 

Monday, August 9, 2021. 

Individuals who need special 

assistance or another reasonable 

accommodation should notify Alaina 

Harris at the address and phone number 

listed above at least 10 business days 

prior to the meeting. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–15569 Filed 7–21–21; 8:45 am] 

BILLING CODE 4165–15–P 


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